Clinical Metadata is a web-based metadata management solution that helps the pharmaceutical industry implement CDISC standards and accelerates the study reporting process.
The tool manages raw, SDTM, ADaM and Analysis Results Metadata, steers users towards CDISC compliance and generates SAS code fragments and submission deliverables. It assists the standards governance process by managing metadata across a standards hierarchy, promoting metadata re-use and saving user time.
Built using the latest enterprise grade technologies, and with a focus on security, transparency and traceability, Clinical Metadata is intuitive to use and promotes collaborative working.
Clinical Metadata is designed and built by a UK team based in London and Warwickshire.
Using the latest technologies to simplify clinical metadata management
Clinical trial metadata management
End-to-end clinical trial meadata management
Raw/ CDASH metadata
Analysis Results Metadata
CDISC Foundational and TA standards
Store metadata within a user defined standards hierarchy
Exchange metadata across a hierarchy
Automatically create Define.xml version 2
Ensure alignment between Define.xml and study metadata
Metadata-driven code generation
Generate SAS code fragments directly from the metadata
Automates repetitive programming
Ensure alignment between programming and metadata
Metadata visualisations from CRF-> Raw->SDTM->ADaM->Output
Securely hosted on the Amazon Web Services (AWS) cloud
Built using enterprise grade technologies
Developed according to Agile methodologies
Project management tools
Inbuilt communication tools
Status tracking of individual programming deliverables
High level summary of study status
Built around the principles of traceability and transparency
Checks for common CDISC compliance issues at data entry
Easy to learn and intuitive to use
Input and output from Define.xml and Microsoft Excel
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